Taxonomy of Medical Devices in the Logic of Health Technology Assessment

Abstract

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA. Keywords: Health technology assessment, Medical devices, ClassificationHealth technologies such as medical devices are an essential part of health care. The European Union defines a medical device as " [ . . . ] any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories [ . . . ]" (1), which includes a broad range of different products for purposes such as prevention, diagnosis, monitoring, treatment, alleviation of disease, or compensation for an injury or handicap (1). Many of these devices have led to important improvements in diagnosis and treatment of diseases such as better health outcomes in terms of higher life expectancy and/or better quality of life (2-4). However, their rapid pace of innovation might also be associated with risks (5) and cause harm to patients. Recent examples arising from the use of medical devices include recalls of specific types of breast implants (6), artificial hips (7), and implantable cardioverter-defibrillators (8). Furthermore, fast-paced innovation is accompanied by rising health expenditures (9;10). The combined imperatives of patient benefit and safety as well as cost containment have led many countries to introduce regulatory instruments to identify technologies that minimize risk and ensure value and value for money.There are two approaches to regulate medic...

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices

“…This diversity creates a considerable hurdle when trying to establish standard procedures for assessment. Currently there is no solution for this problem; it is more a topic for debate (36, 37).…”

“…To simplify the problems of diversity, stratification can be useful. Here, we recommend to: (1) determine whether the device in question is therapeutic, diagnostic, monitoring, or other; (2) differentiate between patient-used, implanted, and assistive for medical personnel; and (3) identify the risk level of the device in the setting in question (36). These categories help the researcher to understand the relevant endpoints and, therefore, suitable types of studies and analysis.…”

Evidence Required by Health Technology Assessment and Reimbursement Bodies Evaluating Diagnostic or Prognostic Algorithms That Include Omics Data

“…MAAAs and other molecular diagnostic algorithms are regulated as in vitro diagnostic (IVD) medical devices (1) in both Europe and the USA Medical device regulation is not formally centralized in Europe, and the IVD rules, under review since 2012 (2), have only recently been promulgated (3). As a result, the legal context surrounding MAAAs is not yet well-defined.…”

Analysis of Duplication and Timing of Health Technology Assessments on Medical Devices in Europe

“…Collaborative efforts on HTA on MDs have substantially increased in recent years. Several initiatives have evaluated barriers for the assessments of MDs, came up with a classification system and developed methodological guidance (4;13;17). The EUnetHTA CoreModel ® provides the methodological framework to facilitate and enhance sharing of results and national uptake of reports and the POP database provides a list of planned and ongoing projects to align work plans (12;14).…”